Recruiting

NDPP-NextGen

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05674799

Conditions

Overweight or Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

NDPP-NextGen

Study Details

Brief summary:

The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy.

The main goals of the study are:

1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI
2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy
3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth

All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:

1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression
2. Body size measurements
3. Fasted blood draws

Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.

Conditions

Overweight or Obesity

Study ID

NCT05674799

Start date

Apr 8, 2023

Status verified date

Feb, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 39

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Established patient at Denver Health or Atrium Health Wake Forest Baptist
  • Biologically female (inclusive of all gender identities)
  • Aged 18-39 years
  • English- or Spanish-speaking
  • BMI ≥25 kg/m2 (≥23 kg/m2 if Asian race)
  • Activities that lead to pregnancy in past 3 months
  • Interested in pregnancy within 24 months, including:

1. High interest (actively trying to conceive)
2. General interest (not actively trying but wanting to become pregnant in the foreseeable future)
3. Neutral interest (not planning pregnancy or using contraception for religious reasons)

Exclusion Criteria:

  • Currently pregnant
  • Non-gestational diabetes (type 1, type 2)
  • Long-acting contraceptives (intrauterine device, implant, injection) with plans to continue for >1 year (barrier \& short-acting hormonal contraception permitted given ease of discontinuing to facilitate pregnancy)
  • Medical procedures (e.g., tubal ligation, hysterectomy) or conditions that impede pregnancy
  • Documented infertility or unsuccessfully trying to conceive for ≥12 months
  • Prior participation in the NDPP
  • History of bariatric surgery
  • Use of GLP-1s in last year
  • Currently receiving clinical obesity treatment

Study Design

Enrollment

403 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Healthy Lifestyle

Women in the Healthy Lifestyle group will be invited to attend the online NDPP-NextGen class which will cover how to eat healthy, be active, and lose weight before getting pregnant. The classes will be led by a trained Lifestyle Coach. Each class lasts about 1 hour. Classes initially meet about once a week (for the first 6 months), then twice a month (for the next 3 months), and then once a month (for the last 3 months). Classes will meet virtually through video-conference. Lifestyle coaches will also call participants in between classes to discuss how participants are doing, answer questions, and provide reminders for upcoming classes. Prior to the first class, women will also participate in a "pre-session" designed to increase NDPP engagement via discussion of diabetes risks and treatment options (i.e., clarify relevance) and motivational interviewing to resolve barriers.

no intervention: Healthy Women

Women in the Healthy Women group get a packet of information standardly given in OB clinics about how to be healthy before, during and after pregnancy.

Interventions

NDPP-NextGen

NDPP-NextGen will incorporate content on preconception/prenatal health into standard NDPP. Participants will be encouraged to make sustainable improvements in diet and activity, but without pre-set goals to better accommodate diverse, low-income populations. Upon pregnancy, recommendations will adjust to support appropriate GWG, breastfeeding, and postpartum weight loss. We will provide education on diet and activity during pregnancy/postpartum, including sufficient energy intake and exercise safety to support the growing fetus. NDPP-NextGen will include 3 strategies to better engage young women. (1) "Pre-sessions" to increase knowledge of diabetes risks, self-efficacy, and readiness to change using motivational interviewing techniques. (2) Delivering classes remotely (via phone- and video-conference) to facilitate participation regardless of inclement weather, dependent care, illness, transportation, etc. (3) Offering classes specially for young women to increase personal relevance.

Primary outcome measure

  • BMI in early pregnancy [ Time Frame: 6-8 weeks gestation ]

Central Contacts and Locations

Central contacts

Katherine A Sauder, PhD

336-716-1280Katherine.Sauder@advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Katherine A Sauder, PhD

336-716-1280Katherine.Sauder@advocatehealth.org

Principal Investigator:

Katherine A Sauder, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Body mass index
  • Pre-conception
  • Diabetes Mellitus
  • Diet
  • Gestational diabetes
  • Neonatal adiposity
  • Maternal and Child Health
  • Overweight
  • Obese
  • Pregnancy
  • Randomized Control Trial
  • Weight
  • adverse maternal outcomes
  • Diabetes Prevention Program
  • glucose
  • gestational weight gain
  • lifestyle intervention
  • usual care
  • remote delivery
  • young women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-02-27.